Nicotine e-cigarettes, counseling aid smoking cessation in randomized trial
In the randomized E3 trial, nicotine e-cigarettes combined with individual counseling was more effective for smoking cessation at 12 weeks than non-nicotine e-cigarettes with counseling or counseling alone.
Mark J. Eisenberg, MD, MPH, professor of medicine at McGill University in Montreal, presented results of the 376-participant randomized trial. Adults who were randomly assigned to nicotine e-cigarettes and smoking-cessation counseling were more likely to continue to abstain from smoking at 12 weeks than those who received counseling only (21.9% vs. 9.1%; RR = 2.5; 95% CI, 1.3-4.6).
Moreover, participants assigned non-nicotine e-cigarettes with individual counseling were also more likely to abstain from smoking compared with those assigned counseling alone (17.3% vs. 9.1%; RR = 1.9; 95% CI, 1-3.8), but less likely than the nicotine e-cigarette arm.
Additionally, participants assigned nicotine e-cigarettes smoked a mean difference of 5.7 fewer traditional cigarettes per day (95% CI, –8 to –3.3) vs. counseling, and those who received non-nicotine e-cigarettes smoked a mean difference of 3.6 fewer per day (95% CI, –6.3 to –1) vs. counseling.
“Nicotine e-cigarettes with individual counseling for 12 weeks is efficacious for smoking cessation compared to counseling alone,” Eisenberg said. “Non-nicotine e-cigarettes with individual counseling has benefits, which appear to be intermediate between those of nicotine e-cigarettes with counseling and counseling alone.”
During the trial treatment period, few serious adverse events occurred. These included one respiratory event (chronic obstructive pulmonary disease exacerbation) in the nicotine e-cigarette arm; one cardiac event (MI) and four other events in the non-nicotine e-cigarette arm; and two other events in the counseling arm. All serious adverse events were adjudicated by the endpoints evaluated committee as deemed unrelated to the treatment participants received. Eisenberg noted that the E3 trial was not powered to look at statistical differences in adverse events.
“Very few serious adverse events occurred during the 12 weeks; however, there clearly remains a need for additional safety data,” Eisenberg said.
Participant enrolled in the E3 trial reported smoking an average of 21 traditional cigarettes per day for 35 years. The mean age at baseline was 53 years. Participants reported their smoking cessation progress via three phone calls and two clinic visits over 12 weeks. Carbon monoxide breath tests verified smoking abstinence.
“Longer-term follow-up data from the E3 trial will help determine if the benefits that we saw will persist over time,” Eisenberg said.
Six- and 12-month follow-up data will be reported in the future, according to Eisenberg.
“As clinicians, we are certainly struggling with whether to recommend e-cigarettes to promote smoking cessation because we have a lack of real data to support whether there’s a clear benefit to this strategy in improving those outcomes,” Eugene Yang, MD, MS, FACC, professor of medicine at the University of Washington School of Medicine, said during a virtual panel discussion.
He noted that a concern is “whether we are really substituting one bad habit for another bad habit.”
“This study clearly shows a small benefit with short-term follow-up at 12 weeks. The intent was to have 52-week follow-up, which you are now conducting. But as we know, the relapse rates are high for those individuals at both 6 and 12 months, and so getting that additional information will certainly be beneficial,” Yang said. – by Scott Buzby
Eisenberg M, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).
Disclosures: Eisenberg and Yang report no relevant financial disclosures.Editor’s note: This article was updated on April 3, 2020, to correct the data on smoking abstinence at 12 weeks. The Editors regret the error.